SRI Biosciences’ Phase 1 Clinical Trial Facility occupies a purpose-built, approximately 9,400 square-foot expansion of the Michigan Life Science and Innovation Center in Plymouth, Michigan, with comprehensive early-stage human research capabilities for new medicines and medical devices.

SRI's experience and resources cover multiple types of vaccines (DNA, subunit protein, live and attenuated virus, peptide, and modified toxins) for conditions including infectious disease, toxins, and cancer. Our Vaccine Development Program also offers assay development and vaccine performance assessments. Services include:

SRI also offers expert consultation on vaccine development strategies and writes detailed product development plans. During the latter stages of the preclinical phase, a full package of regulatory services is available to prepare, assemble, review, deliver and follow up on IND submissions.

Services

Immunogenicity Measurement

Antibody titers

ELISA

Toxin, viral, and microbial neutralization assays

ADCC activity

Cell-mediated immune assays for T-cell activation and function

ELISPOT for single cell activities

Cytometric flow for multiple cytokines

CD4 antigen driven proliferation

CD8 cytotoxic activity

Chemokine analysis

Efficacy Studies

In vitro models (through BSL-3 enhanced, Select Agent)

In animal models (ABSL-2, ABSL-3, ABSL-3 enhanced, Select Agent)

GMP-compliant Vaccine Production

Identify, qualify and manage subcontractors

Develop a formulation

Formulate, fill, and finish

Conduct analytical characterization and stability studies

Develop and perform potency assays

Make antibody against manufacturing cell proteins required for release assay

Preclinical Safety Testing

Consult on study design

Perform GLP toxicology and safety testing

Perform GLP biodistribution and integration studies

Perform GLP reproductive toxicology studies

Regulatory Support

Consultation on strategy and management of FDA interactions

Submission of all meetings and follow-up documentation (e.g., pre-IND)

Staff training for FDA meeting presentations

Clinical protocol design

Conduct of animal rule efficacy studies for biothreat agents

Preparation and submission of all FDA documentation, including INDs, Clinical Investigators' Brochure, and Master Files